Regulatory Affairs Product Associate - Remote

Davita Inc.; Newark (DE); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare company seeks a Regulatory Affairs Product Associate to develop global regulatory strategies and ensure compliance for medical devices. This remote position requires strong regulatory experience, excellent communication skills, and the ability to work collaboratively with diverse teams.

Benefits

Stock Ownership Plan

Profit-sharing opportunities

Flexible benefits

Qualifications

• Minimum 2 years of Regulatory Affairs experience in the medical device industry.
• Experience with US FDA IDE and PMA submissions.
• Experience formulating and implementing regulatory strategies.

Responsibilities

• Plan and prepare regulatory strategies for medical devices.
• Evaluate product labeling and claims for regulatory compliance.
• Coordinate regulatory submissions with functional groups.

Skills

Regulatory strategy formulation

Regulatory compliance

Communication

Interpersonal skills

Project management

Education

Bachelor's degree

Job description

About the Role: We are looking for a Regulatory Affairs Product Associate to join our team with the Cardiac Business Group. In this role, you will Plan, develop, and prepare regulatory strategies and coordinate regulatory planning aimed at achieving and maintaining global marketing approvals or clearances for new,modified, and existing products and develop global regulatory strategies and prepare, write, coordinate, and interactivelyfollow up on global submissions for implantable medical devices.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities:

• Work closely with technical, regulatory affairs, research associates, and product specialists to develop strategies and approaches for obtaining and maintaining regulatory approvals


• Coordinate activities and timelines with applicable functional groups to complete regulatory submissions


• Evaluate product labeling, product claims, advertising, specifications, and changes forregulatory compliance


• Interact closely with and counsel functional groups in the business to provide regulatory guidance and review of their activities


• Integrate into the Regulatory Affairs team to facilitate collaborative and consistentregulatory counsel to product functional groups


• Represent Regulatory Affairs in quality system audits by external agencies


• Assist with post-market compliance requirements


• Collaborate with and counsel the clinical team to ensure notifications and otherreports are submitted as required during the course of clinical trials


• Maintain compliance with training expectations as required for this position


• Additional responsibilities as required within the scope of position

Required Qualifications:

• Bachelor's degree


• Minimum 2 years of Regulatory Affairs experience in the medical device industry


• Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents


• Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, supplied components, packaging, or sterilization


• Successful experience with submissions associated with device modifications and manufacturing process modifications


• Experience proactively identifying necessary submission content and assessing the project documentation, including compliance with international standards


• Experience with US FDA IDE and PMA submissions


• Good communication (oral, written, and interpersonal skills)


• Ability to interact effectively with many diverse functional groups


• Ability to prioritize work and adapt to shifting priorities

Desired Qualifications:

• Experience with Class III design dossiers under the European Medical Device Regulations or filing submissions in another Tier I country


• Experience with regulatory requirements for cardiac devices


• Experience filing required notifications and reports during clinical trials

This position requires access to export-controlled areas and information. Candidates must be "U.S. persons" as that term is defined in 8 USC *1324b(a)(3). The term "U.S. persons" includes resident aliens ("green-card" holders) as well as certain refugees, asylum-holders and residents qualifying for temporary residence under the terms of 8 USC *1255a.

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

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